Sydney, Australia 13 December 2017 – Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that it has been granted Ethics Approval by the St Vincent Hospital (Melbourne) Human Research Ethics Committee for the Company’s clinical trial of SARTATE™ for meningioma.
Clarity filed its ethics submission for the Ethics Committee’s 1st November meeting to run the trial at Royal North Shore Hospital (Sydney) and received approval on 11th December 2017. The Company is planning to complete site set up and commence patient recruitment in the first half of 2018.
The clinical trial is for Peptide Receptor Radionuclide Therapy (PRRT) using 67Cu-SARTATE (copper-67 labelled MeCOSar-Tyr3-octreotate) administered to participants with meningioma. It is a single-centre, open-label, non-randomised, Phase I-IIa theranostic (diagnostic and therapy) clinical trial.
Clarity’s Executive Chairman, Dr Alan Taylor, said “This ethics approval is an important milestone for Clarity as it marks our first human theranostic trial using the perfect pairing of copper-64 and copper-67. The data collected from the study will be invaluable for progressing a number of copper-67 products into therapeutic trials. With already outstanding pre-clinical data for this therapeutic product, we are excited to commence this trial and are looking forward to utilising the results to further progress Clarity’s pipeline and develop therapies for children and adults with cancer.”
Meningioma is a tumour that forms on membranes that cover the brain and spinal cord just inside the skull. Meningiomas are the most common type of tumour that originates in the central nervous system.
SARTATE™ targets somatostatin receptor type 2 (SSTR2), which is expressed in a number of cancers, including meningioma, neuroendocrine tumours and a number of paediatric cancers. Clarity has previously conducted a first-in-human diagnostic clinical trial of 64Cu-SARTATE in neuroendocrine tumour patients, completed in 2015 by Professor Rodney Hicks at the Peter MacCallum Cancer Centre, Melbourne Australia. This therapeutic trial of copper-67 labelled SARTATE™ in meningioma patients will help to pave the way for the use of 67Cu-SARTATE in this patient group as well as for aggressive children’s cancers, such as neuroblastoma.
Clarity Pharmaceuticals is a personalised medicine company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceutical technology, developing targeted therapies and assisting in the drug development pipeline of novel therapies for companies globally.
Dr Alan Taylor
Ph: +61 (0)413 871 165